Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block

Hip Fractures Clinical Trial

Official title:

Comparison Between Bupivacaine-Dexmedetomidine Versus Bupivacaine-Dexamethasone in Pericapsular Nerve Group (PENG) Block as Post-operative Analgesia in Hip Surgeries.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294665
• Other study ID #: MD113/2023
• Status: Recruiting
• Phase: Phase 1
• Start date: March 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: Mohamed AA Salama
• Phone: +201006206630
• Email: m_adel92[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this work is to compare the effectiveness of bupivacaine- dexmedetomidine mixture versus bupivacaine-dexamethasone mixture in PENG Block as Post-operative Analgesia in Hip surgeries

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18-65 years.

2. Sex: Both sexes.

3. American Society of Anaesthesiologists (ASA) Physical Status Class I and II.

4. Scheduled for hip surgeries under spinal anaesthesia.

Exclusion Criteria:

1. Declining to give written informed consent.

2. History of allergy to the medications used in the study.

3. Contraindications to regional anesthesia (including patient refusal, coagulopathy and local infection).

4. Psychiatric disorder.

5. American Society of Anesthesiologists (ASA) Physical Status Class III and IV.

Related Conditions & MeSH terms

• Hip Fractures
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Pericapsular Nerve Group (PENG) Block
The PENG block will be performed ,the patient is placed in the supine position , the procedural leg is slightly abducted, the curvilinear low-frequency ultrasound probe will be placed over the line parallel to the inguinal ligament. It will subsequently rotated 45? to identify the anterior inferior iliac spine, the iliopubic eminence, and the psoas tendon. A 22-gauge, 80 mm echogenic needle will inserted in an in-plane approach to place the tip in the musculofascial plane between the pubic ramus posteriorly and the psoas tendon anteriorly. Following negative aspiration, by one of the two syringes each one has a serial number corresponding to each group.

Locations

Country	Name	City	State
Egypt	Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time to the first request of analgesia	The time interval between the onset of the local infiltration done at the end of the operation and the first request to postoperative analgesia.	9 months
Secondary	Total doses of analgesia (Nalbuphine) given to patients in 24 hours postoperatively		9 months
Secondary	Occurrence of side effects of drugs.		9 months